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November 12, 2021

Biogen and Eisai report Phase III data for Aduhelm in Alzheimer’s disease

Data from trials showed a link between plasma p-tau decline and reduced cognitive, functional decline in Alzheimer’s patients.

Biogen and Eisai have reported that their therapy, Aduhelm (aducanumab-avwa), substantially reduced plasma p-tau181 in two Phase III EMERGE and ENGAGE clinical trials.

A monoclonal antibody, Aducanumab-avwa acts against amyloid-beta.

The latest data from nearly 7,000 plasma samples obtained from more than 1,800 subjects in the Phase III trials showed that there is a statistically significant link between the decline in plasma p-tau, as well as reduced cognitive and functional decline in Alzheimer’s.

In addition, the decline in plasma p-tau181 was linked to reductions in amyloid-beta plaque.

Biogen noted that Aduhelm reduced tau pathology as assessed by plasma p-tau18, which is an Alzheimer’s-specific biomarker, versus placebo in the latest assessment.

In addition, Aduhelm had a greater impact at increased doses and for a longer period of time.

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The statistically significant link between change in plasma p-tau181 and amyloid-beta plaque reduction also demonstrates the impact of Aduhelm treatment on the two crucial pathological features of the disease.

Biogen Research and Development head Alfred Sandrock said: “We now have robust and concordant data that Aduhelm has an effect on two core defining pathologies of Alzheimer’s disease, and substantial evidence of treatment correlation between changes in plasma p-tau181 and the slowing of disease progression.

“We are committed to continuing to generate data, and we believe these new findings can help inform treatment choice and advance Alzheimer’s research including in diagnosis and disease monitoring.”

In July 2021, the companies revealed the design of a real-world observational Phase IV ICARE AD-US study of Aduhelm in Alzheimer’s disease.

This study is intended to obtain real-world data on the long-term efficacy and safety of a 100mg/mL injectable dose of Aduhelm.

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